Executive Director, Pharmacokinetics
The Executive Director, Pharmacokinetics directs the strategy and execution of ADME/PK activities from early discovery to first-in-human trials. Reporting to SVP of Clinical & Nonclinical PK-PD, this role will work closely with Research Biology and leverage expertise in PK-PD and experience in DMPK to innovate novel biologic and small molecule drug products. Collaborates with early development to design fit-for-purpose studies for regulatory submissions. Manages and mentors a staff of subject matter experts in DMPK, bioanalytics, and vivarium management.
- Leads project teams from early discovery through clinical development to identify critical ADME/DMPK needs and formulate strategies to address those issues.
- Integrates in vitro and in vivo ADME results to establish best assays to understand and optimize compound properties in a hypothesis-driven way.
- Delivers data on aggressive timelines to guide medicinal chemistry efforts in optimizing PK.
- Partners with Research Biology, Quantitative Sciences, and Clinical Pharmacology to establish and refine PK-PD-efficacy relationships.
- Collaborates with Toxicology to select appropriate doses and schedules for safety assessments.
- Manages and mentors a staff of DMPK scientists, DMPK bioanalysts, and vivarium specialists.
- Provides detailed supervision of CROs in the execution and design of both standard and novel experiments to understand PK-PD and PK issues.
- Writes and reviews regulatory documents to enable IND and BLA/NDA approvals.
PhD or equivalent in drug metabolism or related field with 15+ years of direct industry experience. Direct experience in discovering and developing drug products (both biologics and small molecules). Team leadership experience with 5+ years as a people manager. Proven ability to drive drug discovery projects from early development through clinical development. Advanced knowledge of bioanalytics, mechanistic in vitro and in vivo experiments to determine the cause of PK issues, and scaling of preclinical DMPK data to predict human PK and dosing schedules. Familiarity with current FDA and EMA guidelines. Ability to collaborate across disciplines. Strong organizational skills, superior communication skills (both written and oral). Demonstrated experience in developing and successfully managing budgets and contracts. Ability to work well under pressure and drive projects that affect critical timelines.
Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.